EP4213846A4 - COMBINATION THERAPY OF A PD-1 ANTAGONIST AND A LAG3 ANTAGONIST AND LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF FOR THE TREATMENT OF PATIENTS WITH CANCER - Google Patents

COMBINATION THERAPY OF A PD-1 ANTAGONIST AND A LAG3 ANTAGONIST AND LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF FOR THE TREATMENT OF PATIENTS WITH CANCER Download PDF

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Publication number
EP4213846A4
EP4213846A4 EP21870037.5A EP21870037A EP4213846A4 EP 4213846 A4 EP4213846 A4 EP 4213846A4 EP 21870037 A EP21870037 A EP 21870037A EP 4213846 A4 EP4213846 A4 EP 4213846A4
Authority
EP
European Patent Office
Prior art keywords
antagonist
lenvatinib
cancer
pharmaceutically acceptable
acceptable salt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP21870037.5A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP4213846A1 (en
Inventor
Jane Anne HEALY
Sujata Shrawankumar JHA
Patricia MARINELLO
Rodolfo Fleury Perini
Jaqueline WILLEMANN ROGERIO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eisai R&D Management Co Ltd
Merck Sharp and Dohme LLC
Original Assignee
Eisai R&D Management Co Ltd
Merck Sharp and Dohme LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eisai R&D Management Co Ltd, Merck Sharp and Dohme LLC filed Critical Eisai R&D Management Co Ltd
Publication of EP4213846A1 publication Critical patent/EP4213846A1/en
Publication of EP4213846A4 publication Critical patent/EP4213846A4/en
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2833—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against MHC-molecules, e.g. HLA-molecules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541—Mucosal route
    • A61K2039/542—Mucosal route oral/gastrointestinal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP21870037.5A 2020-09-15 2021-09-14 COMBINATION THERAPY OF A PD-1 ANTAGONIST AND A LAG3 ANTAGONIST AND LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF FOR THE TREATMENT OF PATIENTS WITH CANCER Withdrawn EP4213846A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063078485P 2020-09-15 2020-09-15
PCT/US2021/050143 WO2022060678A1 (en) 2020-09-15 2021-09-14 Combination therapy of a pd-1 antagonist and lag3 antagonist and lenvatinib or a pharmaceutically acceptable salt thereof for treating patients with cancer

Publications (2)

Publication Number Publication Date
EP4213846A1 EP4213846A1 (en) 2023-07-26
EP4213846A4 true EP4213846A4 (en) 2024-10-02

Family

ID=80777346

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21870037.5A Withdrawn EP4213846A4 (en) 2020-09-15 2021-09-14 COMBINATION THERAPY OF A PD-1 ANTAGONIST AND A LAG3 ANTAGONIST AND LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF FOR THE TREATMENT OF PATIENTS WITH CANCER

Country Status (9)

Country Link
US (1) US20240010729A1 (https=)
EP (1) EP4213846A4 (https=)
JP (1) JP2023543978A (https=)
KR (1) KR20230069957A (https=)
CN (1) CN116457016A (https=)
AU (1) AU2021344849A1 (https=)
CA (1) CA3195058A1 (https=)
MX (1) MX2023003032A (https=)
WO (1) WO2022060678A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20250064794A1 (en) * 2021-08-10 2025-02-27 Eisai R&D Management Co., Ltd. A therapeutic combination comprising a tigit antagonist, a pd-1 antagonist, and lenvatinib
TW202509063A (zh) * 2023-08-21 2025-03-01 瑞士商百濟神州瑞士有限責任公司 用抗lag3、抗pd-1和化學療法治療食管癌

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016141218A1 (en) * 2015-03-04 2016-09-09 Merck Sharp & Dohme Corp. Combination of a pd-1 antagonist and a vegfr/fgfr/ret tyrosine kinase inhibitor for treating cancer
WO2021178657A1 (en) * 2020-03-05 2021-09-10 Merck Sharp & Dohme Corp. Methods for treating cancer using a combination of a pd-1 antagonist, a ctla4 antagonist, and lenvatinib or a pharmaceutically acceptable salt thereof

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017079746A2 (en) * 2015-11-07 2017-05-11 Multivir Inc. Methods and compositions comprising tumor suppressor gene therapy and immune checkpoint blockade for the treatment of cancer
US11045547B2 (en) * 2015-12-16 2021-06-29 Merck Sharp & Dohme Corp. Anti-LAG3 antibodies and antigen-binding fragments
EP3793557A1 (en) * 2018-05-14 2021-03-24 Merck Sharp & Dohme Corp. Biomarkers for a combination therapy comprising lenvatinib and a pd-1 antagonist
CN112839652A (zh) * 2018-08-15 2021-05-25 艾葳生物科技有限公司 VEGF和TGFβ的多激酶抑制剂及其用途
EP3880709A4 (en) * 2018-11-05 2022-07-27 Merck Sharp & Dohme Corp. DOSING REGIME OF ANTI-LAG3 ANTIBODIES AND COMBINATION THERAPY WITH ANTI-PD-1 ANTIBODIES FOR THE TREATMENT OF CANCER
EP3876990A4 (en) * 2018-11-07 2023-09-06 Merck Sharp & Dohme LLC CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016141218A1 (en) * 2015-03-04 2016-09-09 Merck Sharp & Dohme Corp. Combination of a pd-1 antagonist and a vegfr/fgfr/ret tyrosine kinase inhibitor for treating cancer
WO2021178657A1 (en) * 2020-03-05 2021-09-10 Merck Sharp & Dohme Corp. Methods for treating cancer using a combination of a pd-1 antagonist, a ctla4 antagonist, and lenvatinib or a pharmaceutically acceptable salt thereof

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
KATO YU ET AL: "Lenvatinib plus anti-PD-1 antibody combination treatment activates CD8+ T cells through reduction of tumor-associated macrophage and activation of the interferon pathway", PLOS ONE, vol. 14, no. 2, 27 February 2019 (2019-02-27), pages e0212513, XP055790364, Retrieved from the Internet <URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6392299/pdf/pone.0212513.pdf> DOI: 10.1371/journal.pone.0212513 *
LEE CHUNG-HAN ET AL: "Phase II trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) for disease progression after PD-1/PD-L1 immune checkpoint inhibitor (ICI) in metastatic clear cell renal cell carcinoma (mccRCC)", J. CLIN. ONCOL., vol. 38, no. 15 Suppl, 25 May 2020 (2020-05-25), XP093197490, DOI: 10.1200/JCO.2020.38.15_suppl.5008 *
See also references of WO2022060678A1 *
TAYLOR MATTHEW H ET AL: "The LEAP Program: Lenvatinib Plus Pembrolizumab for the Treatment of Advanced Solid Tumors", FUTURE ONCOLOGY, vol. 16, no. 6, 10 December 2020 (2020-12-10), pages 637 - 648, XP093197491, DOI: 10.2217/fon-2020-0937 *

Also Published As

Publication number Publication date
AU2021344849A9 (en) 2025-03-13
CA3195058A1 (en) 2022-03-24
EP4213846A1 (en) 2023-07-26
WO2022060678A1 (en) 2022-03-24
MX2023003032A (es) 2023-06-01
CN116457016A (zh) 2023-07-18
KR20230069957A (ko) 2023-05-19
JP2023543978A (ja) 2023-10-19
AU2021344849A1 (en) 2023-05-25
US20240010729A1 (en) 2024-01-11

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